• José C Nicolau, Ramon Corbalan, Rafael Diaz, Cecilia Bahit, Paul W Armstrong, Christopher B Granger, and Renato D Lopes.
• Heart Institute (InCor), University of São Paulo Medical School, São Paulo, Brazil. corjnicolau@incor.usp.br
• Am. Heart J. 2013 Jun 1; 165 (6): 848-53.

AbstractIn recent years, international clinical trials have increasingly included large numbers of patients and research sites from developing countries. In South America particularly, enrollment in randomized clinical trials has increased substantially. Despite this significant growth of late, there has been little systematic assessment of the role of this region in cardiovascular clinical trials. South America has several strengths with respect to conducting and participating in clinical trials. These include a large population, a high prevalence of cardiovascular diseases, reliable quality of data, a track record of important contributions to previous clinical trials, and good patient adherence and retention in trials. Labor costs also tend to be lower than those in high-income countries. On the other hand, clinical research in this region of the world faces limitations posed by a relatively small clinical trials network with limited operations expertise, as well as prolonged regulatory approval timelines, diversity in health care systems, limited training opportunities in clinical research, and a low patient level of education. Thus, there are many opportunities to improve the conduct of clinical research in South America, but strategies and systems must be developed to overcome barriers in this economically growing region and to establish a robust infrastructure for clinical trials, including high-quality investigator networks.Copyright © 2013 Mosby, Inc. All rights reserved.

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